Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients

Официальное название

Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension

Обзор

Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.

Вмешательства

• Поведенческое Comprehensive Pulmonary Rehabilitation Program
  Combined Aerobic + Resistance Training Program Mode: Cycle ergometry (stationary bicycle) Frequency: 3-5 sessions per week Program Duration: 12 weeks Session Structure: * 5-minute warm-up * Continuous or interval training (15-30 minutes) * 5-minute cool-downesistance Exercise Component Mode: Dumbbell exercises + cycle ergometry Frequency: 3 sessions per week Program Duration: 12 weeks Session Structure: * 5-minute warm-up * Training session (10-20 minutes) * 5-minute cool-down
• Поведенческое Standard Pulmonary Rehabilitation
  xercise Components: Aerobic Exercise Mode: Walking or jogging Resistance Exercise Mode: Elastic bands or dumbbells Training Parameters: Session Duration: ≥35 minutes (combined aerobic + resistance) Frequency: 3-5 sessions per week Program Duration: 12 weeks

Первичные конечные точки

• 6MWD [Срок оценки: 12week]

Критерии участия

Inclusion Criteria:Confirmed PH Diagnosis:

Right heart catheterization-confirmed pulmonary hypertension

Meets 2022 ESC/ERS Guidelines diagnostic criteria for:

• Group 1 (PAH) or
• Group 4 (CTEPH/other pulmonary artery obstructions)

Stabilized Treatment Status:

Group 1 (PAH): Received ≥3 months of targeted drug therapy

Group 4 (CTEPH): Completed ≥6 sessions of BPA\* or reached therapeutic endpoint

Functional Capacity:

WHO Functional Class I-III

Age: ≥18 years

Consent: Willing to provide written informed consent -

Exclusion Criteria:Physical Limitations:

Unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations

Cardiopulmonary Testing Contraindications:

Medically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation

Poor Compliance:

History of non-adherence making protocol completion unlikely

Life Expectancy:

Prognosis ≤1 year

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06973382 · 2025-KE-62-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗